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GW Pharmaceuticals, along with its U.S. subsidiary Greenwich Biosciences, announced that the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration unanimously recommended supporting the approval of the New Drug Application for the investigational cannabidiol oral solution, also known as Epidiolex, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients two years of age and older. If approved, Epidiolex would be the first pharmaceutical formulation of purified, plant-based CBD, a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs. LGS and Dravet syndrome, which develop in childhood, are devastating forms of epilepsy with high morbidity and mortality rates and a significant burden on families and caregivers. More than 90% of patients with LGS or Dravet syndrome have multiple seizures per day, which puts them at constant risk for falls and injury. Physicians who treat LGS and Dravet syndrome patients struggle to reduce the sheer volume of dangerous seizures with currently available therapies. If approved, Epidiolex would be the first-ever FDA-approved medicine for Dravet syndrome patients. "We are pleased by the Advisory Committee's unanimous recommendation to approve Epidiolex, which would provide an important treatment option for patients with LGS and Dravet syndrome, two of the most severe and treatment-resistant forms of epilepsy," said GW's CEO Justin Gover. "This favorable outcome marks an important milestone in our company's unwavering commitment to address the significant unmet need for patients with LGS and Dravet syndrome and our resolve to study Epidiolex under the highest research and manufacturing standards. We look forward to our ongoing discussions with the FDA as it continues to review the Epidiolex NDA."

Leerink analyst Paul Matteis reiterates an Outperform rating on GW Pharmaceuticals, while lowering his price target on the shares to $153 from $154, ahead of CBDV Phase II data in partial-onset seizures in Q1. While he acknowledges that is difficult to garner conviction in the Phase 2, his analysis of pre-clinical results - compared side-by-side to cannabidiol - instills him with "cautious optimism" on the program, while he believes that the little credit priced into the stock for CBDV sets up an upside skewed risk/reward on the upcoming data readout this quarter.

Cantor Fitzgerald analyst Elemer Piros lowered his price target for GW Pharmaceuticals to $192 following the company's Q1 financial results and recent equity raise. The analyst, however, believes the shares remain "significantly undervalued," based on his assessment of Epidiolex's opportunity in treating orphan pediatric epileptic conditions. He reiterates an Overweight rating on GW.

Cantor Fitzgerald analyst Elemer Piros believes GW Pharmaceuticals shares could recover quickly from the selloff on the negative results with GWP42006 in adult patients with focal seizures. The analyst highlights the announcement of an advisory committee hearing for Epidiolex on April 18. The "clear near-term focus" is the successful commercialization of Epidiolex for pediatric pharmacoresistant seizures upon potential approval in the second half of 2018, Piros tells investors in a research note. He keeps an Overweight rating on GW shares with a $192 price target.

Cantor Fitzgerald analyst Elemer Piros raised his price target for GW Pharmaceuticals to $205 and reiterates an Overweight rating on the shares after an FDA advisory committee voted 13-0 that the benefit-risk profile of cannabidiol is favorable for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients two years of age and older.